OBRA '90 reinforces a culture of "give the service away and focus on preserving the buy-sell margin of the product."
An article1 published in a recent edition of Journal of the American Pharmacists Association analyzed 62 randomized clinical trials (RCTs) testing the effects of pharmacists counseling patients on emergency department (ED) and primary-care visits, medication adherence, mortality, and 30-day hospital readmission.
If the results of the counseling had been produced by a device, pharmaceutical, or procedure, it is almost certain that health plans would have called the counseling a defined service and made an explicit payment for patient access.
The authors found that patient counseling produces a 24% decrease in relative risk for 30-day readmissions, a 30% decrease in ED visits, and a 30% increase in relative risk for medication adherence. No changes were found in mortality or primary care, although the time horizons of the studies tended to be less than 1 year.
Omnibus Budget Reconciliation Act of 1990 (OBRA '90)
Second only to the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003, OBRA '90 has had the most retarding effect on the advancement of community-based pharmacy practice through payment for services in the history of the profession. OBRA '90 effectively used Medicaid as a Trojan horse to compel pharmacy providers to offer patient counseling, including drug utilization review to detect drug therapy problems and a host of specific counseling considerations, such as adverse effects, precautions, self-monitoring, and storage. Notably, OBRA '90 requirements are a bit sparse on associating a drug with clinical objectives and conditions for treatment. OBRA '90 also mandated the beginnings of a pharmacist-operated clinical record.
Unfunded Mandates Encourage Race to the Bottom
All these requirements would be fine if attached to a procedure or service code and payment for these services. But, alas, OBRA '90 is one in a long line of policies and ill-fated advocacy that reinforce a culture of "give the service away for free and focus on preserving the buy-sell margin on the product."
Counseling activities increased after passage,2 although reimbursement for product and dispensing fees continued to fall. And we are at the end of the line. Buy-sell margins are below cost for many products and most patients, including the dispensing fee that was supposed to include (ostensibly) the remuneration for the counseling. Dispensing fees are less than $1 in some plans and rarely more than $10.
Without explicit payment for counseling, the service reduces to nothing, forcing pharmacists who want to provide it to do so for free.
Access and Risk of Harm Always Trump Cost Savings
Although I am a strong advocate for value-based care delivery and the death of fee-for-service, we must examine the profession's historical policy and advocacy strategy through a critical lens, as it has largely failed at ensuring payment for services. All care team members get paid for services in their principal setting of care—except pharmacists. Sometimes it is by the profession's own design, and sometimes it has been thrust upon us. In the case of the MMA, we should have demanded that medication optimization services be covered under Part B, rather than through third-party vendor-providers, who also considered medication therapy management a mostly unfunded mandate to reduce average service delivery to the lowest effort possible.
Both of these landmark pieces of legislation came to pass principally for reasons other than pharmacy practice or in advocacy of payment for services. Rather, in both instances, giving away pharmacy services for free, resulting in cost savings, was used to pay for other items in those bills. Not many pharmacists will know or remember that all the hassle associated with calling physicians to require they write tamper-resistant a prescription for Medicaid starting in 2012 was to change the scoring (cost calculations) as an offset to encourage electronic prescribing, fill other budget holes, and fund efforts during the war in Iraq.
Meanwhile, nearly all the gains in payment and scope of practice have resulted from advocacy groups or patients lobbying for access to pharmacist services or showing the harm of not allowing or covering those services as part of a medical benefit. Despite the health system’s desire to move toward value-based remuneration, coverage decisions are still dominated by either fear of denying coverage or economic alignment between manufacturers and third parties not focused on savings but rather on providing patient access at nearly all cost.
Tilting Toward Coverage of New Medications and Procedures
If there were a drug that was the subject of 62 RCTs that produced an aggregate result of 25% or greater reduction in ED visits and hospital readmissions, it would have been covered many moons ago. It also would have cost the health care system more than a $1 dispensing fee to procure in each instance of delivery. A new surgical procedure would produce the same phenomena. In all instances, the focus of advocacy would be on potential denial of coverage, stakeholders finding alignment, and maybe a passing mention of global cost savings. How many RCTs do we need to help policy makers and the public understand the harm associated with lack of payment for making sure that patients know what they are taking why they are taking it, as well as having a simple (or sometimes not so simple) plan of care with a defined therapeutic goal?
100 Billion Reasons to Cover $25 Billion in Patient Counseling
The recent FDA approval of aducanumab (Aduhelm) to reduce plaques associated with Alzheimer disease was based on far fewer studies and less than compelling findings and is estimated to have an impact of up to $100 billion on the Medicare budget. At a predicted list price above $50,000 per year, policy makers blush, but individuals with parents in early decline and individuals such as myself who anticipate parental decline within the next decade want options. Yet, even spending an average of $10 specifically for patient-centered counseling and a documented plan of care to achieve a specific therapeutic outcome for each of roughly 2.5 billion prescriptions filled by more than 60,000 pharmacies across the United States would cost a mere $25 billion.
Let's Have More Rigorous Research on Clinical Outcomes and Studies
Yes, the authors of the study report large costs savings associated with patient counseling that produce “return on investment…[that] may exceed 50:1.”
It is gratifying to know that pharmacists can save a lot of money, yet it has been a tactical error to focus on those savings as the rationale for coverage. If pharmacy is the profession of savings, it will continue to be the profession of unfunded mandates, much like primary care’s preventive care efforts prior to designs in the Affordable Care Act and the Medicare Access and CHIP Reauthorization Act of 2015 to pay for value. If pharmacists are in the profession of keeping patients safe and optimizing therapies, and harm comes to those who do not have access to pharmacists’ talents and time, coverage will ensue rapidly.
Notably, the authors of the meta-analysis also lament poor study design. Give me a solid randomized control trial showing that pharmacists keep patients out of EDs and hospital rooms and get patients to focus on glycated hemoglobin A1C levels, anxiety scales, blood pressure, and depression with the same rigor applied to pharmaceutical trials over an economic analysis any day. And that is saying something coming from an author of many peer-reviewed studies of the latter.
ABOUT THE AUTHOR
Troy Trygstad, PharmD, PhD, MBA, is vice president of pharmacy provider partnerships for Community Care of North Carolina, which works collaboratively with more than 2000 medical practice to serve more than 1.6 million Medicaid, Medicare, commercially insured, and uninsured patients. He received his PharmD and MBA degrees from Drake Universityand a PhD in pharmaceutical outcomes and policy from the University of North Carolina. He also serves on the board of directors of the American Pharmacists Association Foundation and the Pharmacy Quality Alliance.
1. Kelly WN, Ho MJ, Bullers K, Klocksieben F, Kumar A. Association of pharmacist counseling with adherence, 30-day readmission, and mortality: a systematic review and meta-analysis of randomized trials. J Am Pharm Assoc. 2021;61(3):340-350.e5. doi:10.1016/j.japh.2021.01.028
2. Perri M, Kotzan J, Pritchard L, Ozburn W, Francisco G. OBRA ’90: the impact on pharmacists and patients. Am Pharm. 1995;NS35(2):24-28,65. doi:10.1016/s0160-3450(15)30207-5
3. U.S. Troop Readiness, Veterans’ Care, Katrina Recovery, and Iraq Accountability Appropriations ACT, 2007, Public Law 110-28. May 25, 2007. Accessed June 30, 2021. https://www.govinfo.gov/content/pkg/PLAW-110publ28/pdf/PLAW-110publ28.pdf